Prostate Cancer
Conditions
Brief summary
This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy.
Detailed description
The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.
Interventions
DEVICEMultiparametric MRI
MRI will be acquired before, during and after radiation treatment to evaluate treatment response
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Histologically confirmed prostate adenocarcinoma
Exclusion criteria
* Patients with metal fragments or implanted devices such as pacemakers and aneurysm clips are not eligible for the study considering
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response | 2 years | Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control. |
| Tumor Response | 2 years | Tumor response as measured by an increase in PSA. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multi-parametric MRI for Prostate Cancer MRI will be acquired for prostate cancer patients undergoing radiation treatment.
Multiparametric MRI: MRI will be acquired before, during and after radiation treatment to evaluate treatment response | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Multi-parametric MRI for Prostate Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response
Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control.
Time frame: 2 years
Population: Radiomics requires sufficient patient number. Not enough patients were included for radiomics analyses.~PI left institution and country. The data was not collected so analysis could not be completed.
Primary
Tumor Response
Tumor response as measured by an increase in PSA.
Time frame: 2 years
Population: The patient number was too small for the planned radiomics analysis. The study was closed. The data was not collected so analysis could not be completed.~PI left institution and country. Analysis could not be completed.